Multi-direction steerable handles for steering catheters

ABSTRACT

Disclosed herein are steerable catheter assemblies and methods of steering catheters that utilize gimbal plate and ring mechanisms to accomplish independent control of catheter flex magnitude and catheter flex direction. Some embodiments include a catheter with two or more pull wires that flex the catheter, a housing connected to the catheter, a gimbal ring pivotally connected to the housing, a gimbal plate pivotally connected to the gimbal ring to form a gimbal assembly, and an adjustment member coupled to the gimbal assembly, such that the adjustment member is movable axially and rotationally relative to the gimbal assembly. The two or more pull wires are connected to the gimbal plate, the adjustment member engages the gimbal plate such that movement of the adjustment member adjusts the position of the gimbal assembly to thereby flex the catheter with the pull wires.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Non-Provisionalpatent application Ser. No. 15/453,735 filed on Mar. 8, 2017, titled“Cam Controlled Multi-Direction Steerable Handles,” which claims thebenefit of U.S. Provisional Patent Application No. 62/311,031 filed Mar.21, 2016, titled “Cam Controlled Multi-Direction Steerable Handles,” andthis application claims the benefit of U.S. Provisional PatentApplication No. 62/560,576 filed Sep. 19, 2017, titled “Multi-DirectionSteerable Handles for Steering Catheters,” which are all incorporated byreference herein in their entirety.

FIELD

The present disclosure concerns steerable catheter assemblies forsteering an attached catheter or other transluminal device.

BACKGROUND

Transvascular techniques have been developed for introducing andimplanting prosthetic devices, such as heart valves, into a patient'sbody using a flexible transvascular catheter in a manner that is lessinvasive than open heart surgery. Typical catheter control systems onlyallow for limited flexing of the distal end of the catheter, such as intwo orthogonal axes perpendicular to the longitudinal axis of thecatheter. For example, a conventional catheter control handle mayinclude a lever or dial coupled to a pull wire running along one side ofthe catheter, such that actuating the lever or dial causes the distaltip of the catheter to flex radially to one side of the longitudinalaxis. To cause the distal tip to flex in other directions, it istypically required to actuate additional levers/dials that are coupledto other pull wires. Thus, a plurality of actuation devices typicallyhave to be actuated at the same time in careful combinations orsequences to generate a desired degree of radial flex in a desiredcircumferential direction. In this way catheter flex magnitude controland catheter flex direction control are integrated such that it can bedifficult to control and not intuitive to understand.

SUMMARY

Disclosed herein are steerable catheter assemblies that utilize gimbalplate and ring mechanisms to accomplish independent control of catheterflex magnitude and catheter flex direction. Some embodiments include acatheter with two or more pull wires that flex the catheter, a housingconnected to the catheter, a gimbal ring pivotally connected to thehousing, a gimbal plate pivotally connected to the gimbal ring to form agimbal assembly, and an adjustment member coupled to the gimbalassembly, such that the adjustment member is movable axially androtationally relative to the gimbal assembly. The two or more pull wiresare connected to the gimbal plate, the adjustment member engages thegimbal plate such that movement of the adjustment member adjusts theposition of the gimbal assembly to thereby flex the catheter with thepull wires.

The adjustment member can be a pin. In some embodiments, the pin cancomprise a ball attached at an end of the pin, wherein the ball contactsand rolls on the gimbal plate when the pin is rotationally adjusted.

Steerable catheter assemblies can further comprise a rack and pinonmechanism that transfers motion from the gimbal assembly to at least oneof the pull wires. The steerable catheter assemblies can comprise wireguides attached to the gimbal assembly, around which pull wires arelooped. The steerable catheter assemblies can comprise a clutchmechanism configured to selectively fix one of the axial position andthe rotational position of the adjustment member while permittingadjustment of the other of the axial position and the rotationalposition of the adjustment member.

The application discloses methods of steering a catheter by rotating anadjustment member that engages a gimbal plate to adjust a direction ofcatheter flex by adjusting tension in two or more wires, and axiallymoving the adjustment member to change a tilt of the gimbal assemblyrelative to a housing and thereby change a magnitude of catheter flex byadjusting tension in the two or more wires. The axial movement of theadjustment member can independently control a magnitude of flex of thecatheter, and rotational movement of the adjustment member canindependently control a direction of flex of the catheter.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a steerable catheter assemblyincluding independent magnitude and direction control of the attachedcatheter;

FIG. 2 is a perspective view of an exemplarycam-and-follower-controlled, multi-direction control handle for asteerable catheter assembly;

FIG. 3 is an exploded perspective view of the control handle of FIG. 2;

FIG. 4 is a perspective view of an exemplary cam structure;

FIG. 4A is a perspective view of the cam of FIG. 4 with a dwell in thecam contact surface;

FIGS. 5-15 are graphical illustrations of various cam and cam followerarrangements, indicating catheter flex magnitude and direction as afunction of cam and cam follower movements for different user inputs andcam shapes;

FIGS. 16A-16D illustrate exemplary embodiments of different cam shapes;

FIG. 17A illustrates a cam and follower arrangement with threefollowers;

FIG. 17B illustrates a cam and follower arrangement with two followers;

FIGS. 18A and 18B illustrate that the spacing between cam followers canbe non-uniform;

FIG. 19 illustrates an exemplary embodiment of a cam and followerarrangement with two cams;

FIGS. 20A and 20B illustrate an exemplary embodiment of a cam andfollower arrangement where the cam is adjustable in size;

FIG. 21 is a perspective view of a ball-and-socket mechanism andprojection operationally attached to a steerable catheter;

FIG. 22 is a perspective view of the ball-and-socket mechanism andprojection of FIG. 21;

FIG. 23 shows a perspective view of an exemplary multi-direction controlhandle with a cam-and-gimbal mechanism for controlling pull wires for asteerable catheter assembly;

FIG. 24 shows a perspective view of an exemplary multi-direction controlhandle with a projection-and-gimbal mechanism for controlling pull wiresfor a steerable catheter assembly;

FIGS. 25-27 show perspective views of the exemplary multi-directioncontrol handle with a cam-and-gimbal mechanism of FIG. 23 in variouspositions and without pull wires, for illustrative purposes;

FIGS. 28-29 show cross-sectional views of the exemplary multi-directioncontrol handle with a cam-and-gimbal mechanism of FIG. 23 without pullwires for illustrative purposes;

FIGS. 30-32 show perspective views of an exemplary multi-directioncontrol handle with a cam-and-gimbal mechanism for controlling pullwires, wherein the pull wires are doubled back to provide a mechanicaladvantage in the pull wires;

FIG. 33 shows a perspective view of an additional exemplarymulti-direction control handle with a cam-and-gimbal mechanism forcontrolling pull wires, wherein the pull wires are doubled back toprovide a mechanical advantage and a change of direction of the pullwires;

FIG. 34 shows a cross-sectional view of the multi-direction controlhandle of FIG. 33;

FIGS. 35-39 illustrate operation of a multi-direction control handle;

FIG. 40 shows a side view of an exemplary embodiment of a gear rack andpinion assembly that couples pull wires and a gimbal assembly;

FIG. 41 shows a side view of a lever device that can provide mechanicaladvantage in increasing tension in catheter pull wires;

FIG. 42 shows a side view of a pulley device that can provide mechanicaladvantage in increasing tension in catheter pull wires;

FIG. 43 is a perspective view of an exemplary embodiment of a steerablecatheter assembly having a multi-direction control handle and anattached catheter;

FIG. 44A is a side view of a plate with an attached ball in a fixedsocket mechanism and pull wires for use in a steerable catheterassembly;

FIG. 44B is a top-down view of the plate shown in FIG. 44A;

FIGS. 45A and 45B show a side view of a plate and attached deformableball with attached pull wires for use in a steerable catheter assembly;

FIGS. 46A and 46B show a perspective view of a plate suspended from acontrol handle housing with attached pull wires for use in a steerablecatheter assembly;

FIG. 47 shows a perspective view of an embodiment of a multi-directioncontrol handle having a dual threaded nut, follower, and driver;

FIG. 48 shows a sectional view of the multi-direction control handle ofFIG. 47 taken along the plane indicated by lines 48-48 in FIG. 47;

FIG. 49 shows exploded views of the driver and dual threaded nut andfollower mechanisms of the control handle of FIG. 47;

FIG. 50 shows a cut-away view of the multi-direction control handle ofFIG. 47 taken along the plane indicated by lines 50-50 in FIG. 47;

FIG. 51 shows a cut-away view of the control handle of FIG. 50 with thedriver components removed;

FIG. 52 shows an exploded view of the control handle of FIG. 50 with thedriver component removed;

FIG. 53 shows an exploded view of an embodiment of a dual threaded nutand follower assembly;

FIG. 54 shows a perspective view of an embodiment of a control handlewith a planetary gear assembly;

FIGS. 55A-55C show perspective views of the planetary gear assembly ofthe handle illustrated by FIG. 54;

FIGS. 56A-56C show cut-away, perspective views of the planetary gearassembly of the handle illustrated by FIG. 54; and

FIG. 57 shows a top-down, cut-away view of the planetary gear assemblyof the handle illustrated by FIG. 54.

DETAILED DESCRIPTION

As used herein, the singular forms “a,” “an,” and “the” refer to one ormore than one, unless the context clearly dictates otherwise.

As used herein, the term “includes” means “comprises.” For example, adevice that includes or comprises A and B contains A and B but canoptionally contain C or other components other than A and B. A devicethat includes or comprises A or B can contain A or B or A and B, andoptionally one or more other components such as C.

Referring to FIG. 1, the present application relates to steerablecatheter assemblies 1 that utilize various mechanisms to accomplishindependent control of catheter flex magnitude and catheter flexdirection to provide improved steerability of an attached catheter 2.Utilizing a mechanism for determining a circumferential angle and radialmagnitude of catheter flex independently from one another gives the usermore direct, intuitive, and fine control of catheter steering. Theembodiment pictured in FIG. 1 shows a catheter 2 that defines alongitudinal axis extending between proximal end 8 and distal end 9. Thecatheter 2 further defines a circumference C (shown in FIG. 1) thatfurther defines a radius R surrounding the longitudinal axis. Thecatheter 2 can flex radially and is controlled by control handle 5,which can include independent controls for flex magnitude 6, whichdetermines the variable radial distance R of flex of the distal end 9 ofthe catheter 2, and flex direction 7, which is the circumferential anglein which flex of the distal end 9 of the catheter 2 occurs.

FIG. 1 illustrates the flex magnitude control 6 and flex directioncontrol 7 conceptually, as these controls can take a number of forms anduse a variety of mechanisms further described herein. Flex magnitudecontrol 6 and flex direction control 7 may be any knob, lever, switch,dial, device that receives a manual input or a digital input, or otherdevice that is suitable to receive an input from a user to actuate flexmagnitude and flex direction control at a distal end 9 of a catheter 2or other transluminal device. In embodiments disclosed herein, flexmagnitude control 6 and flex direction control 7 determine tension in atleast two pull wires (not pictured in FIG. 1). In embodiments describedherein, at least two pull wires are attached to control handle 5 anddistal end 9 of catheter 2 such that increased tension in a first pullwire in relation to tension in other pull wires pulls the distal end 9of catheter 2 in the direction of one or more of the wires.

In one exemplary method, starting with the attached catheter having astraightened distal tip, the user can adjust the flex magnitude control6 a sufficient amount to cause the distal tip of the catheter to flexradially to a desired angle from the longitudinal axis of thestraightened position (e.g., to a flex angle of 30 degrees fromstraight). This flex can be purely radial, with no circumferentialmotion (e.g., the radial flex can occur while the distal tip is at afixed circumferential angle of zero degrees). Then, the user can adjustthe flex direction control 7 to cause the distal tip of the catheter togradually change the circumferential angle in which the distal tip isradially flexed. For example, adjusting the flex direction control 7 inone way can cause a clockwise change in the circumferential angle of thedistal tip, while adjusting the flex direction control 7 in an oppositeway can cause counter-clockwise change in the circumferential angle.This change in the circumferential angle can be made while maintainingthe degree of radial flex of the distal tip. Furthermore, when the flexdirection control 7 is used to change the circumferential angle of thedistal tip flex, the catheter itself does not need to be rotated insidethe patient. Instead, the distal tip of the catheter is simply flexed ina different circumferential direction from straight while the rest ofthe catheter can remain stationary.

In another exemplary method, starting with the attached catheter havinga straightened distal tip, the user can first adjust the flex directioncontrol 7 to rotate the cam 14 to a selected circumferential positioncorresponding with the desired flex direction of the distal tip of thecatheter 2 (e.g., 270 degrees clockwise from a designated referencepoint). Then, the user can adjust the flex magnitude control 6 asufficient amount to cause the distal tip of the catheter to flexradially in the desired direction to a desired angle from thelongitudinal axis of the straightened position (e.g., to a flex angle of30 degrees from straight). This flex can be purely radial, with nocircumferential motion (e.g., the radial flex from zero to 30 degreescan occur while the distal tip is at the fixed circumferential angle of270 degrees).

FIGS. 2 and 3 illustrate an embodiment of a catheter control handle 5that provides cam-controlled multi-directional steerability for anattached catheter 2 (not pictured in FIGS. 2 and 3, but see FIG. 1). Adistal end 20 of the handle can be coupled to a catheter 2 (see catheter2 in FIG. 1) or other elongated and steerable tubular or transluminaldevice for insertion into a patient, while a proximal end 21 may includeluminal access for passage of other devices, pull wires, and/or fluidsthrough the handle 5 and the attached catheter.

The handle 5 of FIGS. 2 and 3 can comprise a cam member 14 having asloped cam contact surface 15 along which followers 22 slide. Thefollowers 22 are constrained to only axial motion such that they act ascam followers. Followers 22 of the embodiment pictured in FIGS. 2 and 3are sliders though other suitable types of followers, as describedfurther herein, will also function with various other embodiments of thepresent invention. The followers 22 can be coupled to pull wires (notpictured in FIGS. 2 and 3) running along sides of the catheter 2 (seeFIG. 1) such that axial motion of the followers 22 in slots 23applies/adjusts tension on the attached pull wires. Any number offollowers 22 and pull wires can be included.

The handle 5 in FIGS. 2 and 3 can include a first knob 24 (referred toherein as the “flex knob”) that causes axial translation of the cam 14with respect to a longitudinal axis extending between distal end 20 andproximal end 21. The flex knob 24 acts as the flex magnitude control (6of FIG. 1). The handle 5 in FIGS. 2 and 3 can further include a secondknob 25 (referred to herein as the “steering knob”) that causescircumferential rotation of the cam 14 with respect to the longitudinalaxis of the handle 5. The steering knob 25 acts as the flex directioncontrol (7 of FIG. 1). The handle 5 of FIGS. 2 and 3 can furtheroptionally include a third knob 26 (referred to herein as the “clutchknob”) that serves as a clutch or break to lock in the rotationalposition of the cam 14 selected by the steering knob 25 while allowingadjustment to the axial position of the cam via the flex knob 24.

By rotating the flex knob 24, the user can cause the cam 14 to moveaxially relative to the rest of the handle 5, which causes all of thefollowers 22 that are engaged with the cam to move axially acorresponding distance, which in turn causes all of the pull wiresattached to the followers 22 to increase or decrease in tensiontogether, resulting in a change in the magnitude of the radial flex ofthe distal tip (9 in FIG. 1) of the attached catheter, without changingthe circumferential angle of the flexed catheter tip (9 in FIG. 1) withrespect to the longitudinal axis of the catheter.

By rotating the steering knob 25, the user can cause the cam 14 and itssloped contact surface 15 to rotate around the central longitudinal axisof the handle, causing one or more of the followers 22 to move distallyin the slots 23 and one or more other sliders 22 to move proximally inthe slots 23, depending on which part of the sloped contact surface 15is in contact with each follower 22. This can cause increased tension inone or more pull wires and simultaneous reduction in tension in one ormore other pull wires, which results in the flexed distal tip of theattached catheter pivoting about its longitudinal axis and changing thecircumferential angle in which it is radially flexed (without rotatingthe whole catheter inside the patient).

Accordingly, each of the flex knob 24 and the steering knob 25 canindividually adjust some or all of the followers 22 depending on whichfollowers 22 engage the sloped contact surface 15 of cam 14. Each of theknobs 24 and 25 can generate independent, yet complimentary, resultantadjustment to the distal tip of the catheter.

The flex knob 24 and the steering knob 25 can be rotated at the sametime or individually. For example, in an exemplary method, the two knobscan be rotated at the same time (in either the same rotational directionor in opposite rotational directions). Simultaneous rotation of the twoknobs can cause the cam 14 to slide axially and rotate circumferentiallyat the same time, which causes the distal tip of the catheter (9 inFIG. 1) to both change its magnitude of flex and change thecircumferential direction of the flex. The handle 5 can be manuallyoperated with one hand or with two hands. Since the knobs 24 and 25 areclose to each other, the user can operate both knobs with one hand whileholding the handle 5.

As shown in FIGS. 2 and 3, the handle 5 can include a distal nose cone12, a flex component 13 that can include the flex knob 24 and a threadedbody 44, the cam 14, pins 18, a stationary follower guide 41 including adistal body 48 and a proximal body 49 with follower grooves 53,followers 22 each having an outwardly projecting slider pin 54, a backplug 55 with a disk portion 56 and a proximal shaft 58, a positioningcomponent 42 including the steering knob 25 and a proximal cylinder 52with slots/grooves 53, a washer 28, spacers 30, an outer sheath 32, theclutch knob 26, proximal gasket 36, and proximal end cap 38 forming theproximal end 21. Various retainers/fasteners (e.g., retaining rings 57)can also be included. As shown in FIG. 3, the followers 22 can slideaxially along the grooves 53 while their slider pins 54 project out tothe radial dimension of the cam 14. The cam 14 is positioned between theproximal body 49 and the proximal cylinder 52, such that the slider pins54 contact the follower contact surface 15 of the cam 14. The cam 14 canbe coupled to the positioning component 42 such that rotation of thesteering knob 25 causes the cam to rotate, while at the same time theproximal cylinder 52 allows the cam 14 to slide axially between thestationary slider guide 41 and the positioning component 42.

The threaded body 44 of the flex component 13 can be positioned aroundthe distal body 48 of the stationary slider guide 41 and also engaged tothe cam 14 such that rotation of the flex component 13 drives the camaxially relative to the stationary slider guide 41 and the cylinder 52of the positioning component 42.

The clutch knob 26 can have an engaged position and a disengagedposition. When in the engaged position, the steering knob 25 can belocked such that the circumferential angle of the distal tip of theattached catheter is fixed, while allowing the flex knob 24 to drive thecam 14 axially and change the magnitude of flex of the distal tip of theattached catheter. Clutch knob 26 can be configured in an alternateembodiment such that in an engaged position, flex knob 24 is lockedholding the magnitude of flex of the attached catheter constant whileallowing steering knob 25 to rotate the cam 14 circumferentially andchange the circumferential angle of flex. When the clutch knob 26 is inthe disengaged position, both the flex knob 24 and the steering knob 25are functional. In another embodiment, the handle 5 includes two clutchknobs, one for locking the steering knob 25 and one for locking the flexknob 24.

Each of the followers 22 can be attached to one end of a pull wire thatruns distally through the handle 5, out the distal end 20, and along theattached catheter. The handle 5 can include 2 or more followers 22 andassociated pull wires. Four followers 22 are included in the illustratedembodiment, each spaced about 90 degrees apart from each othercircumferentially, though as discussed further below, alternate numbersof followers arranged in different circumferential spacing arrangementscan be used to affect control characteristics of the steerable catheterassembly.

With reference to FIG. 43, which shows the control handle embodiment ofFIGS. 2 and 3 with an attached steerable catheter 2, rotating the flexknob 24 causes the catheter 2 to flex in a radial direction, such as anyof the four exemplary radial directions R1, R2, R3, and R4 labeled inFIG. 43, or any direction in between the labeled directions. When thecam member 16 is in its distal position, i.e. not engaged with anyfollowers 22, the catheter 2 can be relaxed and/or not flexed, such asis shown by the position P1 in FIG. 43. When the cam member is drivenaxially, however, moving the followers 22 with it, the attached pullwires are tensed, causing the catheter 2 to flex radially, for example,to any of the flexed positions labeled P1, P2, P3, or P4 in FIG. 43. Thecircumferential angle in which the catheter 2 flexes is determined bythe position of the steering knob 25. The rotational position of thesteering knob 25 can correspond to circumferential motion of the flexedcatheter 2 in the circumferential direction, labeled with double-headedarrow C in FIG. 43. For example, if the catheter 2 is currently in theflexed position P4, rotation of the steering knob 25 (while the flexknob is stationary) can move the catheter 2 to position P3 or toposition P5 along the dashed line (while the catheter 2 does not rotateabout its central longitudinal axis). If the catheter 2 is currently inthe unflexed position P1, rotation of the steering knob 25 may not causeany motion of the catheter 2 (not even rotation of the catheter 2 aboutits central longitudinal axis), but can determine in which radialdirection (e.g., R1, R2, R3, and R4) the catheter 2 will flex when theflex knob 24 is subsequently rotated. By adjusting the flex knob 24 andthe steering knob 25 in combination (simultaneously or one at a time),the catheter 2 can be steered to any flex position within the dashedcircle in FIG. 43 (assuming the dashed circle represents the maximumdegree of flex), without rotating the catheter 2 about its centrallongitudinal axis within a patient's body.

FIGS. 4 and 4A show embodiments of cam 14 with cam follower contactsurface 15. Dual headed arrow C describes the circumferential directionwith respect to the longitudinal axis L of a control handle in which thecam 14 is housed. The cam 14 is oriented such that contact surface 15can engage followers, and when the cam 14 is adjusted axially orrotationally (circumferentially about the longitudinal axis L), thetension in pull wires coupled to the followers is adjusted. Thus, thecam contact surface 15 can be oriented longitudinally L in proximal ordistal directions with respect to the housing.

FIG. 4 includes a follower contact surface 15 with a constant axialslope as a function of circumferential angle. The contact surface 15 cancomprise any planar or non-planar profile, such as a planar surface thatdefines an oblique plane that is not parallel or perpendicular to thelongitudinal axis of the handle. A cam follower contact surface of thepresent invention can further have shapes and/or slopes including flats,rounds, dwells, divots, valleys, detents, or other shapes. The shape ofthe cam follower contact surface 15 ultimately determines interactionswith the followers when a user provides a flex magnitude or flexdirection input, i.e. the cam 15 is adjusted axially or rotationally.FIG. 4A shows an embodiment of a cam 14 wherein cam follower contactsurface 15 includes a dwell 16. The contact surface 15 can comprise anannular surface that extends circumferentially around a central shaftand/or central lumen of the handle in which the cam 14 is housed. Alumen 17 is shown in FIGS. 4 and 4A that will accommodate such a centralshaft and/or central lumen of the handle through cam 14.

Further discussion of embodiments with alternatively shaped cams isprovided below with reference to FIGS. 12-16D, 20A, and 20B. Thefollower contact surface 15 of the cam 14 can be configured to provide adesired balance between fine control of the flex angles and a minimalamount of control adjustment that is necessary to adjust the flex anglesand magnitude. For example, a steeper slope on the cam results in morechange in radial flex per adjustment of the flex magnitude control,while a less sloped cam surface provides more fine control of the exactmagnitude of flex. Modifications to cam 14 shape allow for furthervariations and adjustments in control and address problems of “drift”that can be present in cam-follower systems as discussed further below.

The use of a cam member in the disclosed control handles can provide aninfinite degree of choice in selecting a desired flex position of thedistal tip of an attached catheter, as the cam member can provide ananalog adjustment mechanism. Furthermore, with regard to the controlhandle 5, an increased number of sliders and/or an increased number ofpull wires that are included and coupled to the followers 22 can improvethe smoothness of the analog control systems described herein.

FIGS. 5-20B graphically illustrate catheter flex as a function of camand follower 22 movement, the interface between cam follower contactsurface 15, the shape of cam contact surface 15, and the number andspacing of followers 22. All cam follower contact surfaces illustratedin the figures are shown extending from point A (displayed on the leftfor illustrative purposes) around to the same point A (displayed on theright for illustrative purposes). This illustration indicates acontinuous cam follower contact surface extending around thecircumference of the longitudinal axis defined by a control handlehousing. FIGS. 5-15, 18A-18B, and 20A-20B are graphical depictions ofembodiments including four followers F1, F2, F3, and F4. Several ofthese figures also depict a continuous arrangement mapped to a line thatextends from left to right, wherein the repetition of one follower (hereF3 indicates the same follower and thus continuity of the followerarrangement).

FIG. 5 graphically depicts an embodiment of a smooth cam followercontact surface 15, like that illustrated in FIG. 4, with fourfollowers, F1, F2, F3, and F4. In FIG. 5, cam follower contact surface15 is axially positioned such that it is not engaged with any of thefollowers. In this position, pull wires coupled to each follower are atminimum tension, thus providing a zero magnitude of flex. FIG. 6 showsthe cam follower contact surface 15 of FIG. 5 after the surface 15 hasbeen axially translated as indicated by arrow D6 causing a correspondingincrease in magnitude of flex R. In the embodiment displayed in FIG. 6,contact surface 15 engages with follower F1 only, thereby increasingtension in the pull wire coupled to follower F1 and pulling the attachedcatheter in the radial direction of F1. Thus, in embodiments disclosedherein, axially adjusting contact surface 15 causes a correspondingadjustment of flex magnitude in the direction of the followers engagedby contact surface 15. FIG. 7 shows the cam follower contact surface 15of FIG. 6 after the cam has been rotated as indicated by arrow E7causing a corresponding change in direction of flex ° C. Rotation of thecam as indicated by arrow E7 causes contact surface 15 to engagefollower F2 while continuing to engage follower F1, but at a differentaxial position. Thus, flex magnitude in the direction of a pull wireattached to F1 is reduced and flex magnitude in the direction of a pullwire attached to F2 is increased, resulting in a directional shift ofthe attached catheter toward F2 in FIG. 7 relative to the catheter'sposition as indicated in FIG. 6. As shown in FIG. 8, further rotation ofthe cam as indicated by arrow E8, causes contact surface 15 tocompletely disengage with follower F1 and engage with follower F2 at anew axial position. Accordingly, flex magnitude in the direction of apull wire attached to F1 is further reduced and flex magnitude in thedirection of a pull wire attached to F2 is further increased, resultingin an additional directional shift of the attached catheter toward F2 inFIG. 8 relative to the catheter's position as indicated in FIG. 7.

FIGS. 9-11 show the positions of the cam surface 15 and followers F1,F2, F3, and F4 after the cam surface has been axially advanced. In FIG.9, the cam surface advances the follower F1 (as compared to FIG. 6) andalso engages and advances followers F2 and F4 to a lesser extent. As aresult, the magnitude of flex in the direction of follower F1 isincreased as compared to FIG. 6. In FIG. 10, the followers F1, F2 areadvanced (as compared to FIG. 7). As a result, the magnitude of flex inthe direction of followers F1, F2 is increased as compared to FIG. 7. InFIG. 11, the follower F2 is advanced (as compared to FIG. 8) and the camalso engages followers F1, F3 to a lesser extent. As a result, themagnitude of flex in the direction of follower F2 is increased ascompared to FIG. 8.

FIGS. 12-15 graphically depict an embodiment of a smooth cam followercontact surface 15 with a dwell 16. In this example, the dwell 16 issized so that the cam surface always engages at least two followers.Four followers, F1, F2, F3, and F4 are illustrated in FIGS. 12-15. FIG.12 shows contact surface 15 axially positioned so that dwell 16 is levelwith the Slack Position Line. The cam embodiment described in FIG. 12does not affect magnitude of catheter flex in this position, where thecam embodiment described in FIGS. 5-11 would in the same axial position.FIG. 13 shows contact surface 15 of the cam and follower systemembodiment described in FIG. 12 translated axially as indicated by arrowD13. In this position, contact surface 15 engages followers F1, F2, andF4. As compared to a follower engaged with a cam without a dwell in thesame axial position, follower F1 does not create as much tension in anattached pull wire and thus does not result in as much flex magnitude inthe direction of the F1 follower. FIG. 14 shows contact surface 15 ofthe cam and follower system embodiment described in FIG. 13 rotated asindicated by arrow E14. In this position, contact surface 15 engagesfollowers F1, and F2, but not F4, to rotate the catheter to the combineddirection between followers F1 and F2. Because followers F1 and F2engage contact surface 15 at dwell 16, followers F1 and F2 are equallyaxially translated, thus exerting equal tension on attached pull wiresand causing equal flex magnitude in the directions of followers F1 andF2. Some further rotation of contact surface 15 as indicated by arrowE14 in FIG. 14 may be made such that the dwell 16 of contact surface 15remains in contact with followers F1 and F2 before follower F3 isengaged. Despite some directional adjustment indicated by arrow E14, nochange occurs in catheter direction. The dwell 16 thus providestolerance for imprecision of adjustments made by a user of embodimentsof steerable catheter assemblies described herein. Insignificant orunintentional adjustments to the directional control by the user caneffectively be “ignored” by the disclosed device when the dwell 16 isused. The size of the dwell can be increased to “ignore” largeradjustments or reduced to have the opposite effect. Further, asdiscussed below, where the length of the dwell at least matches theminimum distance between followers, a dwell solves the problem of“drift.” In FIG. 15, the cam engages the followers F1, F2, F3, and thedirection of catheter flex changes. The dwell also keeps the cam surfacein contact with at least two followers at all times, which prevents thecatheter from jumping from one rotational position to another as the camis rotated.

FIGS. 16A-16D show graphical depictions of alternate embodiments ofcontact surface 15. As discussed above, the cam and follower contactsurface of embodiments of the present invention can comprise any planaror non-planar profile, such as a planar surface that defines an obliqueplane that is not parallel or perpendicular to the longitudinal axis ofthe control handle that houses the cam. A cam follower contact surface15 can comprise shapes and/or slopes including flats, rounds, dwells,divots, valleys, detents, or other shapes. The shape of the cam followercontact surface 15 ultimately determines interactions with the followerswhen a user provides a flex magnitude or flex direction input, i.e. thecam 15 is adjusted axially or rotationally. The follower contact surface15 of the cam 14 can be configured to provide a desired balance betweenfine control of the flex angles and a minimal amount of controladjustment that is necessary to adjust the flex angles and magnitude.For example, a steeper slope on the cam results in more change in radialflex per adjustment of the flex magnitude control, while a less slopedcam surface provides more fine control of the exact magnitude of flex.

FIG. 16A is a graphical depiction of a cam follower contact surface 15,having a dwell 16, and flats 60. FIG. 16B is a graphical depiction of acam follower contact surface 15, having a dwell 16, rounds 62, and flats60. FIG. 16C is a graphical depiction of a cam follower contact surface15, having a dwell 16, flats 60, and a valley or detent 64. Detent 64provides the user with tactile feedback as the detent 64 will provideresistance to rotation of the cam when engaged with a follower, and alsoprovides a directional locking function for finer control. FIG. 16D is agraphical depiction of a cam follower contact surface 15 having a smoothsurface with increasingly steep sides such that for a given rotation ofthe cam, the contact surface quickly engages and then quickly disengagesfollowers. Such a contact surface 15 could provide finer control for anembodiment that includes many followers.

FIGS. 17A and 17B are graphical depictions of cam and follower systemsincluding contact surface 15 and three and two followers, respectively.Lesser numbers of followers decrease fineness of control. Contactsurface 15 as shown in the cam follower system embodiment depicted inFIG. 17B shows contact surface 15 between followers F1 and F2. Contactsurface 15 of FIG. 17B is capable of engaging no followers even for somepositions in which contact surface 15 is axially translated past theSlack Line Position. In such a system, the problem of “drift” ispossible. “Drift” is the process whereby, for a constant axial positionof the cam, a rotation of the cam causes the cam to totally disengagewith all cam followers, thus eliminating tension in attached pull wires.In embodiments described herein, this can correspond with an unexpected(to the user) shift of catheter flex magnitude to zero. As mentionedabove, addition of a dwell can eliminate this problem where the dwell iswide enough to span the maximum gap between followers.

FIGS. 18A and 18B graphically depict cam-follower system embodimentswith variable spacing between followers. FIG. 18A depicts an embodimentwith four followers, F1, F2, F3, and F4, spaced evenly (by distance X₁)around a circumference that is centered on a longitudinal axis of acontrol handle in which the cam-follower system is housed. FIG. 18Bdepicts an embodiment with four followers, F1, F2, F3, and F4, that arenot evenly spaced (by distances X₃, X₄, and X₅) around a circumferencethat is centered on a longitudinal axis of a control handle in which thecam-follower system is housed. As noted above, alternate spacing offollowers can be used to mitigate problems of “drift” or can beconfigured to provide a desired balance between fine control of the flexangles and a minimal amount of control adjustment that is necessary toadjust the flex angles and magnitude in different directions. Forexample, narrower spacing of the followers results in less change inradial flex per adjustment of the flex magnitude control, while largerspacing between followers provides less fine control of the exactmagnitude of flex.

Cam rotation can also be limited to help mitigate drift. FIG. 19graphically depicts a cam that can only be rotated through 90° withrespect to a longitudinal axis of a housing of a control handle in whichthe cam resides. Followers F1 and F2 are spaced 45° apart or lesscircumferentially with respect to the longitudinal axis within the cam'srange of rotation. Accordingly, the cam follower contact surface willalways be in contact with at least one follower F1 or F2 when the cam isaxially advanced beyond the Slack Line Position.

As shown in FIGS. 20A and 20B, in disclosed embodiments, the cam contactsurface 15 can change size and shape as a function of axialdisplacement. In certain disclosed embodiments, the cam is a ribbon cam,made of metal, polymer, or other suitable material that is globallyflexible, but maintains local rigidity for interaction with the camfollowers. FIG. 20B shows a graphical depiction of a cam that becomesincreasingly narrow and increasingly steep as it advances axially fromits position in FIG. 20A to its position in 20B. Such a cam followercontact surface 15 has the advantage that it can provide finer controlthan a uniformly wider cam contact surface by engaging less followerswhen at a greater magnitude while maintaining the benefit of mitigateddrift that comes with a cam with a shallower slope at lower magnitudes.

FIGS. 21-22 illustrate another exemplary control handle 5 comprising aprojection 116 and a ball-and-socket mechanism wherein the socket iscoupled to pull wires such that the orientation of the socket relativeto the ball determines the tension in the pull wires and thus theposition of an attached catheter. Embodiments disclosed herein canfurther comprise a central tubular shaft 102, 103 having a proximal end104 and a distal end 106, a proximal component 110 fixed to the shaft, asocket 112, and a ball 120 mounted on the shaft inside the socket. Theproximal component 110 includes a flex knob 114 and a projection 116that contacts an engagement surface 124 of the socket 112. Therotational orientation of the socket 112 relative to the projection 116(e.g., selected by rotating the socket) determines how the socket 112tilts relative to the ball 120, which determines the circumferentialangle toward which the distal tip of the catheter is directed. The axialposition of the projection 116 relative to the socket 112 (e.g.,selected by rotation of the flex knob 114) determines the magnitude ofaxial flex of the distal tip of the catheter. The socket 112 can havenotches 126 and grooves 128, 130 around its outer perimeter. A pluralityof guidewires can be coupled to the socket around its perimeter by thenotches 126 and grooves 128, 130 and run distally into the catheter.However, the guidewires can be coupled to the socket in any manner.

The radius of the socket 112 can be increased to increase the maximumtension that can be applied to the pull wires (and thus the maximum flexmagnitude of an attached catheter). Pull wires can further be coupled tosocket 112 via rack and pinion or pulley assemblies. As discussedfurther below, such mechanisms provide mechanical advantage thatmagnifies the relative small motions of the projection 116 and socket112 to provide the desired flex in the catheter. The mechanism systemthat couples the steering and flex knobs to the pull wires can beconfigured and/or calibrated to provide the desired balance of finecontrol and range of motion of catheter flex. The ball-and-socketmechanism provides an analog, full 360 degree range of adjustability forcatheter flex, without needing to rotate the catheter inside thepatient.

FIGS. 23-39 illustrate further embodiments of control handles 200 and300 that include a projection that interfaces with a gimbal mechanism tocontrol tension on pull wires that are coupled to an attached catheter.FIGS. 23-32 show handle 200, which comprises a housing 210 having adistal end 212 and a proximal inner cavity 214 that contains a gimbalmechanism comprising an outer gimbal ring 216 and an inner gimbal plate218. The ring 216 is pivotably mounted relative to the housing 210 atpivot joints 250 so that the ring can rotate relative to the housingabout a ring axis passing through joints 250 perpendicular to thelongitudinal axis of the handle. The plate 218 is pivotably mountedrelative to the ring 216 at pivot points 252 such that the plate canrotate relative to the ring about a plate axis passing through joints252 perpendicular to the ring axis. The plate axis and ring axis arerotationally fixed about the housing axis, but the plate can pivotmultidirectionally relative to the housing as the ring pivots relativeto the housing through joints 250 and as the plate pivots relative tothe ring through joints 252.

Control handle 200 further comprises two or more pull wires 222. Thegimbal plate 218 can include wire engagements 220 for each pull wire 222of the handle. Four pull wires 222 are illustrated as an example inFIGS. 23-32. Each wire 222 passes through passageways 226 in the handleand extends out from distal openings 228 into an attached catheter orother similar steerable device. The wires 222 can optionally loop aroundrespective wire engagements 220 in the gimbal plate 218, as illustratedin FIGS. 23 and 24, such that end portions 224 of the wires extend backto fixed attachment points on the housing. In such embodiments, the wireengagements 220 can comprise a rounded peg, pulley, or other feature tofacilitate the wires sliding around the wire engagement with minimalfriction and kinking as the plate articulates. This arrangement canprovide mechanical advantage, effectively halving the pulling forceapplied to the wires while causing the distal ends of the wires in thecatheter to move at twice the rate that the wire engagements in theplate move. In alternative embodiments, the wires can terminate at thewire engagements 220 in the gimbal plate without any mechanicaladvantage, which can avoid bending the wires.

In embodiments disclosed herein, the handle 200 includes a central shaft230 that has a distal end 232 coupled to the housing 210, anintermediate portion that passes through an opening 219 in the gimbalplate 218 and through projection 234, and a proximal portion that isfixedly coupled to a flex knob 240. The distal end 232 is coupled to thehousing via a rotational bearing that allows rotation of the shaft 230and flex knob 240 relative to the housing and gimbal mechanism, butprevents longitudinal motion of the shaft 230 and flex knob 240 relativeto the housing and gimbal mechanism. Although not shown, the centralshaft 230 and flex knob 240 can include a central lumen extendingthrough their entire length. The housing 210 can also include a centrallumen that extends from the distal end of the shaft 230 to the distalend 212 of the handle. Combined, the central lumens of the handle 200can provide access for other devices and/or fluids to be passed into andout of a patient through the handle and through a connecting lumen in anattached catheter. Projection 234 can be a cam as pictured in FIG. 23 orother projection such as a projection comprising a pin or a pin with aball rollably attached at a distal end of the pin such that the ballrolls on gimbal plate 218 as depicted in FIG. 24.

The handle 200 also includes a steering knob 242 that can include anindicator nub 244 that is fixedly coupled to the projection 234 andpositioned around the central shaft 230 distal to the flex knob 240 inFIGS. 23-32. The projection 234 and/or steering knob 242 can bethreadedly or helically engaged to the outer surface of the centralshaft 230. As illustrated in FIG. 27, when the flex knob 240 and centralshaft 230 are rotated (arrow 1) relative to the steering knob 242 andcam member 234 (e.g., by holding the steering knob stationary relativeto the housing 210 and turning the flex knob relative to the housing210), the steering knob and cam member are driven distally (arrow 2) orproximally relative to the housing and gimbal mechanism, causing thegimbal plate to pivot (arrow 3) and change tension on all the pullwires.

By using the flex knob 240 to drive the cam member distally orproximally, the magnitude of the flex of the catheter is adjusted.Distal motion of the cam causes the gimbal plate to tilt more, causingincreased magnitude of flex, and proximal motion of the cam memberallows the gimbal plate to return closer to its natural positionperpendicular to the longitudinal axis of the handle, reducing the flexof the catheter. Rotating the flex knob 240 causes the catheter to flexin the circumferential direction (with respect to the longitudinal axisdefined by the handle 200) determined by the position of the gimbal as aresult of the rotation of the projection 234 about the longitudinal axisdefined by the handle 200. The circumferential angle in which thecatheter flexes is determined by the position of the steering knob 244,which rotates the projection with respect to the gimbal plate 218.

FIGS. 30-32 illustrate rotation of the steering knob 242 to change thecircumferential angle at which the catheter radially flexes. Therotational position of the steering knob 242 can be visually and/ortactilely indicated by the nub 244 or other indicator. The steering knob242 and the attached projection 234 can be rotated 360 degrees relativeto the gimbal mechanism about the central shaft. The rotational positionof the steering knob determines where a distal end of the projection 234contacts the gimbal plate 218, and thus the direction in which thegimbal plate tilts when the flex knob 240 is used to drive theprojection 234 into the gimbal plate 218.

The gimbal ring 216 and gimbal plate 218 work together to allow theplate to tilt in any direction, and thus flex the attached catheter inany radial direction. In FIG. 30, the ring 216 is stationary and theplate 218 tilts about the plate axis, pulling on wire G and relaxingwire F. This causes the catheter to flex in the direction of the wire G.In FIG. 31, the ring 218 rotates about the ring axis and the plate 216rotates about the plate axis, pulling both wires G and H, and relaxingwires F and K. This causes the catheter to flex in a direction betweenwires G and H. In FIG. 12, the plate 218 is stationary relative to thering 216, and the ring and plate rotate in unison about the ring axis,pulling on wire H and relaxing wire K. This causes the catheter to flexin the direction of the wire H.

In some embodiments, the gimbal plate can have a non-planar contactsurface, with bump(s) and/or valley(s) which vary in heightcircumferentially and/or radially on the gimbal plate. These cancompensate for any discretization effect of not using an infinite numberof pull wires around the perimeter of the plate. For example, when thecam member pushes on the gimbal plate between two wires, it may need alittle extra pull on the pull wires in order to get the same amount offlex at the distal end of the catheter. These bumps or valleys canachieve that extra pull by tilting the plate a little more or less atcertain circumferential and radial cam contact locations. For example,if a completely planar gimbal plate is used, a slight unflexing mayoccur when the steering knob is adjusted such that the flex direction isbetween two of the pull wires. Including a gradual bump on the gimbalplate in the location between the pull wire engagements (as just oneexample) can compensate for that expected unflexing by tilting thegimbal plate a little more when the cam contacts that bump, therebyproviding the additional pull wire motion needed to maintain a constantflex magnitude in a direction between two pull wires.

FIGS. 33-39 illustrate embodiments of control handle 300, which includesa projection that interfaces with a gimbal mechanism to control tensionon at least two pull wires. The control handle 300 functions in asimilar manner to the control handle 200, with the major differencebeing the catheter is connected to the opposite longitudinal end of thehandle and the pull wires double back and extend out from the oppositelongitudinal end of the handle, flipping the distal and proximaldirections compared to the handle 200.

The handle 300 comprises a housing 310, a proximal end 314, and a distalend 312 at or near flex knob 322. The flex knob 322 is axially fixedrelative to a central shaft 320, and a steering knob 324 is positionedaround and/or within the flex knob in a threaded engagement or helicalinterface such that rotation of the flex knob drives the steering knoband projection 326 axially relative to the gimbal mechanism inside thehousing. The gimbal mechanism includes a gimbal ring 316 pivotablymounted inside the housing about a ring axis and a gimbal plate 318pivotably mounted inside the ring via pivots along a plate axisperpendicular to the ring axis, like with the handle 200. The handle 300can also include a wire guide plate 330 mounted inside the housing 310proximal to the gimbal mechanism.

Each pull wire in the handle 300 can have an end 340 fixed to wire guideplate 330, a first portion extending from the wire end 340 distally tothe gimbal plate 318 and around pulleys or other guides 342 in thegimbal plate, a second portion that extends back proximally from thegimbal plate to secondary pulleys or guides 344 in the wire guide plate330, then around the pulleys or guides 344, and a third portion thatextends distally through the central shaft 320 along the length of thehandle and out through the distal end 312 of the handle into a cathetercoupled to the handle.

FIG. 35 illustrates how rotating the flex knob 322 (arrow 4) causes theprojection 326 to move axially (arrow 5), and causes the distal edge ofthe projection 326 to tilt the gimbal plate 318 and/or ring 316 (arrow6), which adjusts the magnitude of flex in the attached catheter.

FIG. 36 shows the handle 300 with the gimbal ring 316 and plate 318 in arelaxed position when the projection is not tilting ring 316 or plate318. In this state, the attached catheter can be in a relaxed,non-flexed neutral position. FIG. 37 shows the projection 326 advancedproximally, tilting the gimbal plate 318 while the gimbal ring 316remains stationary. This causes flex of the attached catheter in aselected radial direction. FIG. 38 shows the projection 326 rotated afew degrees from its position in FIG. 37, such that both the gimbalplate and ring are pivoted. This causes the attached catheter to beflexed about the same magnitude but in a correspondingly differentradial direction compared to the flex magnitude in FIG. 37. In FIG. 39,the projection 326 is rotated about 90 degrees from its position in FIG.37, such that the gimbal ring is pivoted relative to the housing 310,but the gimbal plate is not pivoted relative to the gimbal ring. In thisposition, the attached catheter is flexed about the same radial amountas in FIGS. 37 and 38, but it is flexed in a direction that is about 90degrees from the direction corresponding with the catheter position inFIG. 37.

As the gimbal plate 318 moves relative to the wire guide plate 330, thepull wires articulate around the wire guides 342 and 344 in the twoplates, providing a mechanical advantage that magnifies the relativesmall motions of the cam member and gimbal plate to provide the desiredflex in the catheter. Like with the handle 200, the mechanism thatcouples the knobs 322 and 324 to the pull wires can be configured and/orcalibrated to provide the desired balance of fine control and range ofmotion of catheter flex. The gimbal mechanism of control handle 300 alsoprovides an analog, full 360 degree range of adjustability for thecatheter flex, without needing to rotate the catheter inside thepatient. Further, as with the gimbal plate 218 of control handle 200,the radius of gimbal plate 318 can be increased to increase the maximumtension that can be applied to the pull wires (and thus the maximum flexmagnitude of an attached catheter).

FIG. 40 is a schematic diagram that illustrates an alternative handlesystem 400 for coupling a gimbal mechanism to pull wires without loopingor curling the pull wires. The system 400 includes a housing 410 with agimbal ring 412 and gimbal plate 414 mounted inside the housing, fixedrack gears 416 mounted in fixed relationship to the housing, moving rackgears 422 opposing each fixed rack gear 416 and coupled to the pullwires 424, rolling pinion gears 418 engaged between the fixed and movingrack gears, and rigid connector members 420 coupled from the gimbalplate 414 to the center of each pinon gear 418. A projection (not shown)causes motion of the gimbal mechanism, which pulls and pushes on therigid connector members 420, causing the pinion gears 418 to rollcorrespondingly along the fixed rack gears 416. For each unit ofdistance the pinion gears 418 roll, the moving rack gears 422 move inthe same direction but twice as far, creating mechanical advantage thatmagnifies the motion of the projection into greater motion of the pullwires, but without pulleys or other devices that require the pull wiresto be curled or bent around sharp angles, which can damage the wiresover time. While this embodiment describes a rack and pinion assemblythat is particular to a gimbal mechanism-based control handle, the rackand pinion assembly can similarly be implemented in any of the otherembodiments described herein by coupling followers to pull wires using arack and pinion assembly.

FIGS. 41 and 42 show side views of a lever assembly 4100 and a pulleyassembly 4200, respectively. In FIG. 41, a short end 4102 of the leverarm 4104 is connected to a wire 4106 that is coupled to the handlemechanism. A long end 4112 of the lever arm is connected to a catheterpull wire 27. As such, the motion of the wire 4106 is multiplied in thepull wire 27 by the lever assembly. In FIG. 42, a small hub 4202 of thepulley assembly 4200 is connected to a wire 4206 that is coupled to thehandle mechanism. A larger hub 4212 of the pulley assembly is connectedto a catheter pull wire 27. As such, the motion of the wire 4206 by thehandle mechanism is multiplied in the pull wire 27 by the pulleyassembly 4200. These assemblies can similarly be implemented in any ofthe other embodiments described herein by coupling followers to pullwires using the assemblies to gain mechanical advantage to magnifyrelative small motions to provide the desired flex in the distal end ofan attached catheter.

FIG. 44A illustrates an embodiment of an assembly 500 that interfaceswith a projection (not shown) to control tension on at least two pullwires 27. Assembly 500 is a plate 530 attached to a ball 510 that isrotatably mounted in a socket base 520. The socket base 520 is fixed toa housing of a control handle (not shown). The ball 510 rotates in thedirections indicated by the arrows N, thus allowing the plate 530 torotate and tilt in the directions indicated by arrows M and N. At leasttwo pull wires 27 are attached to the plate 530 on one axial side of theplate 530. Though pull wires 27 are shown attached on the opposite axialside of the plate 530 as the side to which the ball 510 is attached, thepull wires 27 may be attached to the plate 530 on the same axial side asthe ball 510, depending on the orientation of the socket base 520 andthe pull wires 27 within the control handle housing. FIG. 44Billustrates the plate 530 from an axial side view. In the embodimentshown, holes 531 provide attachment points for the pull wires 27 in theplate 530. Further, as with the gimbal plate and ball-and-socketembodiments, the radius of the plate 530 can be increased to increasethe maximum tension that can be applied to the pull wires 27 (and thusthe maximum flex magnitude of an attached catheter).

FIGS. 45A and 45B illustrate an embodiment of an assembly 600 thatinterfaces with a projection (not shown) to control tension on at leasttwo pull wires 27. Assembly 600 is a plate 630 attached to a deformableball 610 that is in contact with a surface 620. The surface 620 is partof or fixed to a housing of a control handle (not shown). The deformableball 610 deforms in response to tilt of the plate 630, which inembodiments disclosed herein is accomplished by the axial or rotationalmovement of a projection (not shown), thus allowing the plate 630 torotate and tilt multidirectionally. FIG. 45B shows the deformable ball610 in a deformed configuration after the tilt of the plate 630indicated by arrow P in FIG. 45A. At least two pull wires 27 areattached to the plate 630 on one axial side of the plate 630. Thoughpull wires 27 are shown attached on the opposite axial side of plate 630as the side to which the deformable ball 610 is attached, the pull wires27 may be attached to the plate 630 on the same axial side as deformableball 610, depending on the orientation of surface 620 and the pull wires27 within the control handle housing. Further, as with the gimbal plate,ball-and-socket, and assembly 500 embodiments, the radius of the plate630 can be increased to increase the maximum tension that can be appliedto the pull wires 27 (and thus the maximum flex magnitude of an attachedcatheter).

FIGS. 46A and 46B illustrate an embodiment of an assembly 700 thatinterfaces with a projection (not shown) to control tension on at leasttwo pull wires 27. Assembly 700 is a plate 730 suspended from a housingof a control handle (not shown) by at least one suspension wire 710. Atleast one suspension wire 710 allows the plate 730 to tiltmultidirectionally, which in embodiments disclosed herein isaccomplished in response to the axial or rotational movement of aprojection (not shown), thus applying a force to one axial side of theplate 730. FIG. 46B shows suspended plate 730 in a tilted position afterthe projection applies a force to plate 730 as indicated by arrow Q inFIG. 46A. At least two pull wires 27 are attached to plate 730 on oneaxial side of the plate 730. The pull wires 27 are attached on the axialside of plate 730 that is opposite the suspending wire 710. Theprojection, however, can apply a force on either axial side of plate 730to control tension on the at least two pull wires 27. Further, as withthe gimbal plate, ball-and-socket, assembly 500, and assembly 600embodiments, the radius of the plate 730 can be increased to increasethe maximum tension that can be applied to the pull wires 27 (and thusthe maximum flex magnitude of an attached catheter).

FIGS. 47-53 show views of embodiments and components of a cathetercontrol handle 800 that provides steerability for an attached catheter(not pictured in FIGS. 47-53). A distal end 812 of the handle 800 can becoupled to a catheter (see catheter 2 of system 5 in FIG. 43) or otherelongated and steerable tubular or transluminal device for insertioninto a patient, while a proximal end 814 may include luminal access forpassage of other devices, pull wires, and/or fluids through the handle800 and the attached catheter.

With reference to FIGS. 48 and 49, the control handle 800 includes adrive nut 830, a first follower 831 and a second follower 832respectively, and a driver 857 disposed inside of control handle 800.The followers 831, 832 are attached to pull wires (not shown). Thedriver 857 axially translates in response to adjustments of a drive knobor a flex knob 824 and causes axial motion of the drive nut 830. Theaxial motion of the drive nut 830 causes equal axial motion in the firstand second followers 831, 832, in turn causing an equal adjustment inthe tension of two pull wires (not shown). This adjustment in tensioncauses an adjustment in the magnitude of radial flex of the attachedcatheter (not shown).

The drive nut 830 rotates in response to adjustments of the flex knob825. The rotation of the drive nut 830 causes the first and secondfollowers 831, 832 to move in opposite axial directions. Rotating thesteering knob 825 in one direction causes one follower to travel axiallytoward its attached pull wire and one follower to travel axially awayfrom its attached pull wire, thereby creating greater tension in onepull wire and reducing tension in the other. This causes the attachedcatheter to flex in the direction of the tensed wire. Rotating steeringknob 825 in the opposite direction causes the opposite effect on theaxial motion of the followers 830, 831, thereby causing the attachedcatheter to flex in the direction of the other tensed wire. Thus,steering knob 825 controls direction of flex of an attached catheter.Embodiments of control handle 800 may further include cap 875 andhousing 860.

In embodiments disclosed herein and as shown in FIGS. 48-49, the driver857 is comprised of a threaded drive screw 850 and a threaded driveshaft 851. In the control handle 800, adjusting the drive knob 825causes rotation of threaded drive screw 850, which is engaged withinternal threads of the drive shaft 851. Rotation of the threaded drivescrew 850 causes the drive shaft 851 to move axially. A coupling 856 isformed between the end of the drive shaft 851 and the end of the drivenut 830. As such, the axial movement of the drive shaft results inpushing or pulling of the dual threaded nut 830. Since the first andsecond followers 831 and 832 are in the dual threaded nut 830, the firstand second followers are moved by an equal axial amount. In theembodiment shown in FIGS. 48 and 49, the drive coupling 856 couplesdrive shaft 851 and dual threaded nut 830 such that distal or proximalaxial motion of drive shaft 851 causes the same motion in dual threadednut 830.

In FIGS. 50-53, the steering mechanism of the control handle 800comprises the dual threaded nut 830, a follower guide 840 with followerslots 841, and a nut rotator 861. The first and second followers 831,832 reside in different follower slots 841 of the follower guide 840.The follower guide 840 is stationary with respect to housing 860 and therotator 861. When steering knob 825 is adjusted, nut rotator 861 rotatesthe dual threaded nut 830 with respect to housing 860 (without axialmotion of dual threaded nut 830 relative to housing 860).

As shown in FIG. 53, dual threaded nut 830 is cut with internal, dual,left and right threads 833. First follower 831 has external, left-handthreads. The threads of first follower 831 engage the left-hand set ofthreads in dual threaded nut 830. Second follower 832 has external,right-hand threads. The threads of second follower 832 engage theright-hand set of threads in dual threaded nut 830. For the same turn ofdual threaded nut 830 by the rotator 861, the first and second followers831, 832 move in opposite axial directions in follower slots 841 withrespect to housing 860 as a result of their opposite threading. Attachedpull wires correspondingly tense or relax depending on the axialdirection of movement of the followers 831 and 832. The pull wires (notshown) are routed through a pull wire guide 855 and to the proximal endof the handle 800.

FIGS. 54-57 are views of an exemplary embodiment of a catheter controlhandle 900 that provides steerability for an attached catheter 2 (notpictured in FIGS. 54-57). A distal end 914 of the handle 900 can becoupled to a catheter (see catheter 2 of system 5 in FIG. 43) or otherelongated and steerable tubular or transluminal device for insertioninto a patient. A luminal access 970 can extend from a proximal end 912to the distal end 914 for passage of other devices, pull wires, and/orfluids through the handle 900 and the attached catheter.

The illustrated control handle 900 includes a first follower 931, asecond follower 932, a third follower 933, and a fourth follower 934. Afirst driver 924 is coupled to the first and second followers 931 and932, which are circumferentially oppositely disposed from one another. Asecond driver 925 is coupled to the third and fourth followers 933 and934, which are also circumferentially oppositely disposed from oneanother and are positioned about 90° from the first and second followers931, 932. Rotation of the first driver 924 moves the first and secondfollowers 931 and 932 in opposite axial directions with respect tocontrol handle 900. Rotation of the second driver 925 moves the thirdand fourth followers 933 and 934 in opposite axial directions withrespect to control handle 900. Pull wires attached to followers thatmove proximally with respect to the housing 860 increase in tension andpull wires attached to followers that move distally relax. The attachedcatheter flexes in the direction of the tensed pull wires. Thus, controlof magnitude and direction of flex is not independent for control handle900. First and second drivers 924 and 925 may be rotatable drive ringswith internal teeth 945.

As shown in section views with housing 960 removed in FIGS. 55A-57,control handle 900 can further comprise first, second, third, and fourthdrive gears 941, 942, 943, and 944 respectively and first, second,third, and fourth drive screws 951, 952, 953, and 954 respectively. Thedrive screws are rotatably attached to the housing 960 and each drivegear is fixed to its corresponding drive screw such that rotation of adrive gear causes rotation of its corresponding drive screw withoutaxial motion of the drive screw or drive gear with respect to thehousing 960. In disclosed embodiments, first and second drive gears 941and 942 engage internal teeth 945 of first driver 924, and third andfourth drive gears 943 and 944 engage internal teeth 945 of seconddriver 925. Further, first and third drive screws 951 and 953 areleft-hand threaded, and second and fourth drive screws 952 and 954 areright-hand threaded. First and third followers 931 and 933 are set withinternal left-hand threads and respectively engage the threads of firstand third drive screws 951 and 953. Second and fourth followers 932 and934 are set with internal right-hand threads and respectively engage thethreads of second and fourth drive screws 952 and 954. Rotation of firstdriver 924 causes equal rotation of first and second drive gears 941 and942 and thus of first and second drive screws 951 and 952. Firstfollower 931 and second follower 932 move in opposite axial directionsin response, because of their opposite threading. The attached catheterflexes in the direction of the follower that moves proximally and thustenses its attached pull wire. Rotation of second driver 925 causesequal rotation of third and fourth drive gears 943 and 944 and thus ofthird and fourth drive screws 953 and 954. Third follower 933 and fourthfollower 934 move in opposite axial directions in response, because oftheir opposite threading. The attached catheter flexes in the directionof the follower that moves proximally and thus tenses its attached pullwire.

It should be understood that the disclosed embodiments can be adapted todeliver and implant prosthetic devices in any of the native annuluses ofthe heart (e.g., the pulmonary, mitral, and tricuspid annuluses), andcan be used with any of various approaches (e.g., retrograde, antegrade,transseptal, transventricular, transatrial, etc.). The disclosedembodiments can also be used to implant prostheses in other lumens ofthe body. Further, in addition to prosthetic valves, the deliveryassembly embodiments described herein can be adapted to deliver andimplant various other prosthetic devices such as stents and/or otherprosthetic repair devices. In other embodiments, the disclosed devicescan be used to perform various other transvascular surgical proceduresother than implanting a prosthetic device.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms may vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

As used in this application and in the claims, the term “coupled”generally means physically, electrically, magnetically, and/orchemically coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user/operator of the deviceand further away from an end or destination of the device within apatient's body (e.g., the heart). As used herein, the term “distal”refers to a position, direction, or portion of a device that is furtheraway from the user/operator of the device and closer to the end ordestination of the device within a patient's body. Thus, for example,proximal motion of a catheter is motion of the catheter out of the bodyand/or toward the operator (e.g., retraction of the catheter out of thepatient's body), while distal motion of the catheter is motion of thecatheter away from the operator and further into the body (e.g.,insertion of the catheter into the body toward the heart). The terms“longitudinal” and “axial” refer to an axis extending in the proximaland distal directions, unless otherwise expressly defined.

As used herein, the terms “integrally formed” and “unitary construction”refer to a one-piece construction that does not include any welds,fasteners, or other means for securing separately formed pieces ofmaterial to each other.

As used herein, operations that occur “simultaneously” or “concurrently”occur generally at the same time as one another, although delays in theoccurrence of one operation relative to the other due to, for example,spacing, play or backlash between components in a mechanical linkagesuch as threads, gears, etc., are expressly within the scope of theabove terms, absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosure may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of the disclosedtechnology is at least as broad as the following claims. We thereforeclaim as our invention all that comes within the scope of these claimsas well as their equivalents.

We claim:
 1. A steerable catheter assembly comprising: a catheter withtwo or more pull wires that flex the catheter; a housing connected tothe catheter; a gimbal ring pivotally connected to the housing; a gimbalplate pivotally connected to the gimbal ring to form a gimbal assembly;an adjustment member coupled to the gimbal assembly, such that theadjustment member is movable axially and rotationally relative to thegimbal assembly; wherein the two or more pull wires are connected to thegimbal plate; and wherein the adjustment member engages the gimbal platesuch that movement of the adjustment member adjusts the position of thegimbal assembly to thereby flex the catheter with the two or more pullwires.
 2. The steerable catheter assembly of claim 1, wherein axialmovement of the adjustment member controls a magnitude of flex of thecatheter and rotational movement of the adjustment member controls adirection of flex of the catheter.
 3. The steerable catheter assembly ofclaim 2, wherein a magnitude control that axially moves the adjustmentmember is selected from the group consisting of a lever, a knob, a dial,or a device that receives a digital input.
 4. The steerable catheterassembly of claim 1, wherein a direction control causes rotationaladjustment of the adjustment member.
 5. The steerable catheter assemblyof claim 4, wherein the direction control is selected from the groupconsisting of a lever, a knob, a dial, and a device that receives adigital input.
 6. The steerable catheter assembly of claim 1, whereinthe adjustment member is a pin.
 7. The steerable catheter assembly ofclaim 6, further comprising a ball attached at an end of the pin,wherein the ball contacts and rolls on the gimbal plate when the pin isrotationally adjusted.
 8. The steerable catheter assembly of claim 1,wherein the two or more pull wires are looped around wire guides thatare attached to the gimbal plate.
 9. The steerable catheter assembly ofclaim 1, further comprising a rack and pinon mechanism that transfersmotion from the gimbal plate to at least one of the two or more pullwires.
 10. The steerable catheter assembly of claim 1, furthercomprising a clutch mechanism configured to selectively fix one of anaxial position and a rotational position of the adjustment member whilepermitting adjustment of the other of the axial position and therotational position of the adjustment member.
 11. The steerable catheterassembly of claim 1, wherein axial movement of the adjustment memberindependently controls a magnitude of flex of the catheter androtational movement of the adjustment member independently controls adirection of flex of the catheter.
 12. The steerable catheter assemblyof claim 1, wherein a direction of radial flex can be adjusted withoutrotating the catheter about a longitudinal axis of the catheter.
 13. Acontrol handle for a steerable catheter comprising: two or more pullwires that are configured to flex the catheter; a housing; a gimbal ringpivotally connected to the housing; a gimbal plate pivotally connectedto the gimbal ring to form a gimbal assembly; an adjustment membercoupled to the gimbal assembly, such that the adjustment member ismovable axially and rotationally relative to the gimbal assembly;wherein the two or more pull wires are connected to the gimbal plate;and wherein the adjustment member engages the gimbal plate such thatmovement of the adjustment member adjusts the position of the gimbalassembly to thereby control the two or more pull wires.
 14. The controlhandle of claim 13, wherein axial movement of the adjustment membercontrols a magnitude of pulling by the two or more pull wires androtational movement of the adjustment member controls a direction ofpulling by the two or more pull wires.
 15. The control handle of claim14, wherein a magnitude control that axially moves the adjustment memberis selected from the group consisting of a lever, a knob, a dial, or adevice that receives a digital input.
 16. The control handle of claim13, wherein a direction control causes rotational adjustment of theadjustment member.
 17. The control handle of claim 16, wherein thedirection control is selected from the group consisting of a lever, aknob, a dial, and a device that receives a digital input.
 18. Thecontrol handle of claim 13, wherein the adjustment member is a pin. 19.The control handle of claim 18, further comprising a ball attached at anend of the pin, wherein the ball contacts and rolls on the gimbal platewhen the pin is rotationally adjusted.
 20. The control handle of claim13, wherein the two or more pull wires are looped around wire guidesthat are attached to the gimbal plate.
 21. The control handle of claim13, further comprising a rack and pinon mechanism that transfers motionfrom the gimbal plate to at least one of the two or more pull wires. 22.The control handle of claim 13, further comprising a clutch mechanismconfigured to selectively fix one of an axial position and a rotationalposition of the adjustment member while permitting adjustment of theother of the axial position and the rotational position of theadjustment member.
 23. The control handle of claim 13, wherein axialmovement of the adjustment member independently controls a magnitude ofpulling of the two or more pull wires and rotational movement of theadjustment member independently controls a distribution of pullingbetween the two or more pull wires.
 24. A prosthetic system comprising:a steerable catheter assembly comprising: a catheter with two or morepull wires that flex the catheter; a housing connected to the catheter;a gimbal ring pivotally connected to the housing; a gimbal platepivotally connected to the gimbal ring to form a gimbal assembly; anadjustment member coupled to the gimbal assembly, such that theadjustment member is movable axially and rotationally relative to thegimbal assembly; wherein the two or more pull wires are connected to thegimbal plate; and wherein the adjustment member engages the gimbal platesuch that movement of the adjustment member adjusts the position of thegimbal assembly to thereby flex the catheter with the two or more pullwires; and a prosthetic device coupled to the steerable catheterassembly.
 25. The prosthetic system of claim 24 wherein the prostheticdevice is a heart valve.